NCT03562052

Brief Summary

The good clinical practice guidelines for the surveillance of workers after occupational exposure to lung carcinogens were approved by the Haute Autorité de la Santé (French National Authority for Health) and the Institut National du Cancer (French National Cancer Institute) in December 2015 and one recommendation of these guidelines concerns the setting-up of a trial of low-dose chest computed tomography (CT) lung cancer screening in subjects occupationally exposed to lung carcinogens at high-risk of lung cancer (Expert consensus). In LUCSO study, the investigators propose to conduct, under strictly defined conditions, a feasibility study of lung cancer screening in a population defined as being at high risk of lung cancer according to these good clinical practice guidelines. This population consists of smokers, aged from 55 to 74 years, currently or previously exposed to International Agency for Research on Cancer lung group 1 lung carcinogens. The primary objective of this study is to evaluate the complex organization of lung cancer screening in the target population. This evaluation will focus on the following indicators:

  • Screening activity indicator: screening coverage rate over two years
  • Test quality indicator: validity of self-administered questionnaires to target the high-risk population
  • Examination quality indicator: lung cancer detection rate, lung cancer detection rates by stage, validity of low-dose chest CT scan
  • Follow-up indicator: smoking cessation rate, mortality rate This trial will be conducted in 8 French departments, by six reference centers specialized in occupational health (SRC). In view of the exploratory nature of this trial, it is proposed to initially test the feasibility and acceptability of lung cancer screening sequentially over the first two years (Phase 1: 2021-2023, 24 months) in only two SRC (Val-de-Marne and Gironde). The trial will be conducted in several steps:
  • Identification of subjects currently or previously occupationally exposed to lung carcinogens by a screening invitation letter sent by Departmental Cancer Screening Centers to subjects aged from 55 to 74 years.
  • Evaluation of occupational exposure to lung carcinogens
  • Evaluation of the lung cancer risk level and verification of eligibility
  • Screening procedure: Chest CT scans will be performed by centers specialized in chest imaging
  • Lung cancer follow-up when an abnormality suggestive of lung cancer is demonstrated.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
64mo left

Started Jul 2021

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Jul 2021Jul 2031

First Submitted

Initial submission to the registry

April 16, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
3.1 years until next milestone

Study Start

First participant enrolled

July 22, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2031

Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

4.9 years

First QC Date

April 16, 2018

Last Update Submit

July 8, 2024

Conditions

Lung Cancer

Keywords

CancerLungOccupational carcinogensTobacco smokingScreeningChest CT ScanAsbestos

Outcome Measures

Primary Outcomes (1)

  • Rate of detected lung cancer

    The proportion of subjects with lung cancer detected among the subjects performing the low-dose chest CT scan

    Year 1

Secondary Outcomes (67)

  • Rate of detected lung cancer

    Year 2

  • Rate of detected lung cancer

    Day 0

  • Participation rate

    Day 0

  • Rate of detected lung cancer in subjects exposed to occupational carcinogens

    Day 0

  • Rate of detected lung cancer in subjects exposed to occupational carcinogens

    Year 1

  • +62 more secondary outcomes

Eligibility Criteria

Age55 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects aged from 55 to 74 years, current smokers smoking 30 pack-years or more or ex-smokers smoking 30 pack-years or more and who have quit smoking for less than 15 years and currently or previously occupationally exposed to lung carcinogens. These subjects are known to be high-risk population for lung cancer.

You may qualify if:

  • Subjects at high risk of lung cancer: current smokers smoking 30 pack-years or more or ex-smokers smoking 30 pack-years or more and who have quit smoking for less than 15 years and currently or previously occupationally exposed to lung carcinogens. With an algorithm for determination of minimal duration of exposure to occupational carcinogens (according to the type and duration of occupational lung carcinogens)

You may not qualify if:

  • Presence of clinical signs of lung cancer
  • Subjects with a history of lung cancer
  • Presence of serious short-term life-threatening comorbidities
  • Absence of occupational exposure to lung carcinogens according to the predefined criteria
  • Subjects already included in another prospective cohort study
  • Subjects already assessed by chest CT scan during the previous year
  • No tobacco exposure or insufficient tobacco exposure or smoking cessation for more than 15 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33076, France

RECRUITING

Université de Bordeaux

Bordeaux, 33076, France

ACTIVE NOT RECRUITING

Centre Hospitalier Universitaire de Brest

Brest, 29609, France

NOT YET RECRUITING

Centre Hospitalier Universitaire de Caen

Caen, 14033, France

NOT YET RECRUITING

Centre Hospitalier Intercommunal de Créteil

Créteil, 94010, France

RECRUITING

Centre Hospitalier Universitaire de Rennes

Rennes, 35033, France

NOT YET RECRUITING

Centre Hospitalier Universitaire de Rouen

Rouen, 76032, France

NOT YET RECRUITING

Hôpital d'Instruction des Armées Sainte-Anne

Toulon, 83000, France

NOT YET RECRUITING

Related Publications (1)

  • Delva F, Laurent F, Paris C, Belacel M, Brochard P, Bylicki O, Chouaid C, Clin B, Dewitte JD, Le Denmat V, Gehanno JF, Lacourt A, Margery J, Verdun-Esquer C, Mathoulin-Pelissier S, Pairon JC. LUCSO-1-French pilot study of LUng Cancer Screening with low-dose computed tomography in a smokers population exposed to Occupational lung carcinogens: study protocol. BMJ Open. 2019 Mar 23;9(3):e025026. doi: 10.1136/bmjopen-2018-025026.

    PMID: 30904859DERIVED

MeSH Terms

Conditions

Lung NeoplasmsNeoplasmsTobacco Smoking

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesSmokingBehaviorTobacco Use

Study Officials

  • Jean-Claude Pairon, Pr

    Centre Hospitalier Interconnmunal de Créteil

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Claude Pairon, Pr

CONTACT

157022093JC.Pairon@chicreteil.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2018

First Posted

June 19, 2018

Study Start

July 22, 2021

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 31, 2031

Last Updated

July 9, 2024

Record last verified: 2024-07

Locations

FR(8)